U.S. patent application number 09/827740 was filed with the patent office on 2002-10-10 for minimally invasive apparatus for implanting a sacral stimulation lead.
Invention is credited to Carlton, Keith Richard, Gerber, Martin Theodore, Mamo, George, Spinelli, Michele, Swoyer, John Matthew.
Application Number | 20020147485 09/827740 |
Document ID | / |
Family ID | 46277495 |
Filed Date | 2002-10-10 |
United States Patent
Application |
20020147485 |
Kind Code |
A1 |
Mamo, George ; et
al. |
October 10, 2002 |
Minimally invasive apparatus for implanting a sacral stimulation
lead
Abstract
Methods and apparatus for implanting a stimulation lead in a
patient's sacrum to deliver neurostimulation therapy that can
reduce patient surgical complications, reduce patient recovery
time, and reduce healthcare costs. A surgical instrumentation kit
for minimally invasive implantation of a sacral stimulation lead
through a foramen of the sacrum in a patient to electrically
stimulate a sacral nerve comprises a needle and a dilator and
optionally includes a guide wire. The needle is adapted to be
inserted posterior to the sacrum through an entry point and guided
into a foramen along an insertion path to a desired location. In
one variation, a guide wire is inserted through a needle lumen, and
the needle is withdrawn. The insertion path is dilated with a
dilator inserted over the needle or over the guide wire to a
diameter sufficient for inserting a stimulation lead, and the
needle or guide wire is removed from the insertion path. The
dilator optionally includes a dilator body and a dilator sheath
fitted over the dilator body. The stimulation lead is inserted to
the desired location through the dilator body lumen or the dilator
sheath lumen after removal of the dilator body, and the dilator
sheath or body is removed from the insertion path. If the clinician
desires to separately anchor the stimulation lead, an incision is
created through the entry point from an epidermis to a fascia
layer, and the stimulation lead is anchored to the fascia layer.
The stimulation lead can be connected to the neurostimulator to
delivery therapies to treat pelvic floor disorders such as urinary
control disorders, fecal control disorders, sexual dysfunction, and
pelvic pain.
Inventors: |
Mamo, George; (Ellicott
City, MD) ; Spinelli, Michele; (Milano, IT) ;
Swoyer, John Matthew; (Andover, MN) ; Gerber, Martin
Theodore; (Maple Grove, MN) ; Carlton, Keith
Richard; (Minneapolis, MN) |
Correspondence
Address: |
Eric R. Waldkoetter
Medtronic, Inc., MS LC340
710 Medtronic Parkway
Minneapolis
MN
55432-5604
US
|
Family ID: |
46277495 |
Appl. No.: |
09/827740 |
Filed: |
April 7, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09827740 |
Apr 7, 2001 |
|
|
|
09713598 |
Nov 15, 2000 |
|
|
|
Current U.S.
Class: |
607/116 ;
607/115 |
Current CPC
Class: |
A61N 1/0551
20130101 |
Class at
Publication: |
607/116 ;
607/115 |
International
Class: |
A61N 001/00 |
Claims
What is claimed is:
1. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter extending from the lead body
proximal end and lead body distal end, the lead body further
enclosing at least one electrical conductor extending between at
least one proximally located electrical connector adapted to be
coupled to an electrical stimulation pulse generator and at least
one distally located stimulation electrode adapted to apply
electrical stimulation to a sacral nerve, the kit comprising: a
needle having a needle diameter and needle length extending from a
needle distal end capable of penetrating body tissue and a needle
proximal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; and a dilator having
a dilator body diameter, a dilator body length extending between a
dilator proximal end and a dilator distal end, and a dilator body
lumen extending from the dilator proximal end to the dilator distal
end and having a dilator body lumen diameter sized in operative
relation to the lead body diameter and the needle diameter to
selectively receive the needle and the lead body therein, whereby
the dilator is adapted to be inserted over the needle proximal end
to locate the needle within the dilator body lumen and to be
advanced distally over the needle through the insertion path to
dilate the insertion path to the dilator diameter, the needle is
adapted to be withdrawn through the dilator body lumen, the
stimulation lead is adapted to be advanced through the dilator body
lumen to locate the stimulation lead electrode into operative
relation to the sacral nerve, and the dilator is adapted to be
withdrawn over the stimulation lead body.
2. The kit as in claim 1, further comprising: means for creating an
incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
3. The kit as in claim 1, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode end and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
4. The kit as in claim 3, wherein the needle body is marked by
depth marks enabling visualization of the depth of insertion of the
needle through the insertion path and the depth of insertion of the
dilator over the needle body.
5. The kit as in claim 1, wherein the needle comprises a needle
body marked by depth marks enabling visualization of the depth of
insertion of the needle through the insertion path and the depth of
insertion of the dilator over the needle body.
6. The kit as in claim 1, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
7. The kit as in claim 1, wherein the dilator diameter is in the
range from about 0.33 mm to about4.00 mm.
8. The kit as in claim 1, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
9. The kit as in claim 1, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
10. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter and enclosing at least one
electrical conductor extending between at least at least one
proximally located electrical connector adapted to be coupled to an
electrical stimulation pulse generator and at least one distally
located stimulation electrode adapted to apply electrical
stimulation to a sacral nerve, the kit comprising: a needle having
a needle diameter, a needle length extending from a needle distal
end capable of penetrating body tissue and a needle proximal end,
and a needle lumen extending from the needle proximal end and
needle distal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; a guide wire having a
guide wire diameter sized to fit through the needle lumen and a
guide wire length extending between a guide wire proximal end and a
guide wire distal end, the guide wire adapted to be inserted
through the needle lumen to locate a distal portion of the guide
wire through the foramen of the sacrum; and a dilator having a
dilator body diameter, a dilator body length extending between a
dilator proximal end and a dilator distal end, and a dilator body
lumen extending from the dilator proximal end to the dilator distal
end and having a dilator body lumen diameter sized in operative
relation to the lead body diameter and the guide wire diameter,
whereby the needle is adapted to be withdrawn over the guide wire,
the dilator is adapted to be inserted over the guide wire proximal
end to locate the guide wire within the dilator body lumen and to
be advanced distally over the guide wire through the insertion path
to dilate the insertion path to the dilator diameter, the guide
wire is adapted to be withdrawn through the dilator body lumen, the
stimulation lead is adapted to be advanced through the dilator body
lumen to locate the stimulation lead electrode into operative
relation to the sacral nerve, and the dilator is adapted to be
withdrawn over the stimulation lead body.
11. The kit as in claim 10, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
12. The kit as in claim 10, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
13. The kit as in claim 12, wherein the needle comprises a needle
body marked by depth marks enabling visualization of the depth of
insertion of the needle through the insertion path
14. The kit as in claim 10, wherein the guide wire is marked by
depth marks enabling visualization of the depth of insertion of the
guide wire through the needle lumen to locate the guide wire distal
end through the foramen of the sacrum and enabling visualization of
the depth of insertion of the dilator over the guide wire.
15. The kit as in claim 10, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm..
16. The kit as in claim 10, wherein the dilator diameter is in the
range from about 0.33 mm to about 4.00 mm.
17. The kit as in claim 10, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
18. The kit as in claim 10, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
19. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter extending from the lead body
proximal end and lead body distal end, the lead body further
enclosing at least one electrical conductor extending between at
least one proximally located electrical connector adapted to be
coupled to an electrical stimulation pulse generator and at least
one distally located stimulation electrode adapted to apply
electrical stimulation to a sacral nerve, the kit comprising: a
needle having a needle diameter and needle length extending from a
needle distal end capable of penetrating body tissue and a needle
proximal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; and a dilator having
a dilator body diameter, a dilator body length extending between a
dilator proximal end and a dilator distal end, and a dilator body
lumen extending from the dilator proximal end to the dilator distal
end and having a dilator body lumen diameter sized in operative
relation to the lead body diameter and the needle diameter to
selectively receive the needle and the lead body therein so that
the dilator is insertable over the needle proximal end to locate
the needle within the dilator body lumen to be capable of being
advanced distally over the needle through the insertion path to
dilate the insertion path to the dilator diameter and to allow the
needle to be withdrawn through the dilator body lumen and to allow
the stimulation lead to be advanced through the dilator body lumen
to locate the stimulation lead electrode in operative relation to
the sacral nerve and to allow the dilator to be withdrawn over the
stimulation lead body.
20. The kit as in claim 19, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
21. The kit as in claim 19, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
22. The kit as in claim 21, wherein the needle comprises a needle
body marked by depth marks enabling visualization of the depth of
insertion of the needle through the insertion path and the depth of
insertion of the dilator over the needle body.
23. The kit as in claim 19, wherein the needle comprises a needle
body marked by depth marks enabling visualization of the depth of
insertion of the needle through the insertion path and the depth of
insertion of the dilator over the needle body.
24. The kit as in claim 19, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
25. The kit as in claim 19, wherein the dilator diameter is in the
range from about 0.33 mm to about 4.00 mm.
26. The kit as in claim 19, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
27. The kit as in claim 19, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
28. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter and enclosing at least one
electrical conductor extending between at least at least one
proximally located electrical connector adapted to be coupled to an
electrical stimulation pulse generator and at least one distally
located stimulation electrode adapted to apply electrical
stimulation to a sacral nerve and a lead body lumen extending from
the lead body proximal end and lead body distal end, the kit
comprising: a needle having a needle diameter, a needle length
extending from a needle distal end capable of penetrating body
tissue and a needle proximal end, and a needle lumen extending from
the needle proximal end and needle distal end, the needle adapted
to be grasped by a medical clinician with the needle distal end
directed toward and inserted through an entry point of the skin or
a skin incision posterior to the sacrum and guided along an
insertion path into a foramen to locate at least a distal portion
of the needle extending alongside a sacral nerve and a proximal
portion of the needle extending from the entry point away from the
patient's skin; a guide wire having a guide wire diameter sized to
fit through the needle lumen and the stimulation lead lumen and a
guide wire length extending between a guide wire proximal end and a
guide wire distal end, the guide wire adapted to be inserted
through the needle lumen to locate a distal portion of the guide
wire through the foramen of the sacrum enabling withdrawal of the
needle over the guide wire; and a dilator having a dilator body
diameter, a dilator body length extending between a dilator
proximal end and a dilator distal end, and a dilator body lumen
extending from the dilator proximal end to the dilator distal end
and having a dilator body lumen diameter sized in operative
relation to the guide wire diameter to enable insertion of the
dilator over the guide wire proximal end to locate the guide wire
within the dilator body lumen, to enable advancement of the dilator
distally over the guide wire through the insertion path to dilate
the insertion path to the dilator diameter, and to allow the guide
wire to be withdrawn through the dilator body lumen, the dilator
body lumen sized with respect o the lead body diameter to allow the
stimulation lead to be advanced through the dilator body lumen to
locate the stimulation lead electrode into operative relation to
the sacral nerve and to allow withdrawal of the dilator over the
stimulation lead body.
29. The kit as in claim 28, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
30. The kit as in claim 28, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
31. The kit as in claim 30, wherein the needle body is marked by
depth marks enabling visualization of the depth of insertion of the
needle through the insertion path.
32. The kit as in claim 28, wherein the guide wire is marked by
depth marks enabling visualization of the depth of insertion of the
guide wire through the needle lumen to locate the guide wire distal
end through the foramen of the sacrum and enabling visualization of
the depth of insertion of the dilator over the guide wire.
33. The kit as in claim 28, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
34. The kit as in claim 28, wherein the dilator diameter is in the
range from about 0.33 mm to about 4.00 mm.
35. The kit as in claim 28, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
36. The kit as in claim 28, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
37. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter extending from the lead body
proximal end and lead body distal end, the lead body further
enclosing at least one electrical conductor extending between at
least one proximally located electrical connector adapted to be
coupled to an electrical stimulation pulse generator and at least
one distally located stimulation electrode adapted to apply
electrical stimulation to a sacral nerve, the kit comprising: a
needle having a needle diameter and needle length extending from a
needle distal end capable of penetrating body tissue and a needle
proximal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; and a dilator
comprising a dilator body having a dilator body diameter, a dilator
body length extending between a dilator proximal end and a dilator
distal end, and a dilator body lumen extending from the dilator
proximal end to the dilator distal end and having a dilator body
lumen diameter sized in operative relation to the needle diameter
to receive the needle therein, the dilator further comprising a
dilator sheath having a dilator sheath diameter, a dilator sheath
length extending between a dilator sheath proximal end and a
dilator sheath distal end, and a dilator sheath lumen extending
from the dilator sheath proximal end to the dilator sheath distal
end and having a dilator sheath lumen diameter sized in operative
relation to the lead body diameter and the dilator body diameter to
selectively receive the dilator body and the lead body therein,
whereby the dilator sheath and dilator body are adapted to be
assembled with the dilator body received within the dilator sheath
lumen, the dilator body is adapted to be inserted over the needle
proximal end to locate the needle within the dilator body lumen and
to be advanced distally over the needle through the insertion path
to dilate the insertion path to the dilator sheath diameter, the
needle is adapted to be withdrawn through the dilator body lumen,
the dilator body is adapted to be withdrawn through the dilator
sheath lumen, the stimulation lead is adapted to be advanced
through the dilator sheath lumen to locate the stimulation lead
electrode into operative relation to the sacral nerve, and the
dilator sheath is adapted to be withdrawn over the stimulation lead
body.
38. The kit as in claim 37, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
39. The kit as in claim 37, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode end and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
40. The kit as in claim 39, wherein the needle body is marked by
depth marks enabling visualization of the depth of insertion of the
needle through the insertion path and the depth of insertion of the
dilator over the needle body.
41. The kit as in claim 37, wherein the needle comprises a needle
body marked by depth marks enabling visualization of the depth of
insertion of the needle through the insertion path and the depth of
insertion of the dilator over the needle body.
42. The kit as in claim 37, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
43. The kit as in claim 37, wherein the dilator sheath diameter is
in the range from about0.33 mm to about 4.00 mm.
44. The kit as in claim 37, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
45. The kit as in claim 37, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
46. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter and enclosing at least one
electrical conductor extending between at least at least one
proximally located electrical connector adapted to be coupled to an
electrical stimulation pulse generator and at least one distally
located stimulation electrode adapted to apply electrical
stimulation to a sacral nerve, the kit comprising: a needle having
a needle diameter, a needle length extending from a needle distal
end capable of penetrating body tissue and a needle proximal end,
and a needle lumen extending from the needle proximal end and
needle distal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; and a guide wire
having a guide wire diameter sized to fit through the needle lumen
and the stimulation lead lumen and a guide wire length extending
between a guide wire proximal end and a guide wire distal end, the
guide wire adapted to be inserted through the needle lumen to
locate a distal portion of the guide wire through the foramen of
the sacrum; and a dilator comprising a dilator body having a
dilator body diameter, a dilator body length extending between a
dilator proximal end and a dilator distal end, and a dilator body
lumen extending from the dilator proximal end to the dilator distal
end and having a dilator body lumen diameter sized in operative
relation to the guide wire diameter to receive the guide wire
therein, the dilator further comprising a dilator sheath having a
dilator sheath diameter, a dilator sheath length extending between
a dilator sheath proximal end and a dilator sheath distal end, and
a dilator sheath lumen extending from the dilator sheath proximal
end to the dilator sheath distal end and having a dilator sheath
lumen diameter sized in operative relation to the lead body
diameter and the dilator body diameter to selectively receive the
dilator body and the lead body therein, whereby the dilator sheath
and dilator body are adapted to be assembled with the dilator body
received within the dilator sheath lumen, the dilator body is
adapted to be inserted over the guide wire proximal end to locate
the guide wire within the dilator body lumen and to be advanced
distally over the guide wire through the insertion path to dilate
the insertion path to the dilator sheath diameter, the guide wire
is adapted to be withdrawn through the dilator body lumen, the
dilator body is adapted to be withdrawn through the dilator sheath
lumen, the stimulation lead is adapted to be advanced through the
dilator sheath lumen to locate the stimulation lead electrode into
operative relation to the sacral nerve, and the dilator sheath is
adapted to be withdrawn over the stimulation lead body.
47. The kit as in claim 46, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
48. The kit as in claim 46, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode end and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
49. The kit as in claim 48, wherein the needle body is marked by
depth marks enabling visualization of the depth of insertion of the
needle through the insertion path.
50. The kit as in claim 46, wherein the guide wire is marked by
depth marks enabling visualization of the depth of insertion of the
guide wire through the needle lumen to locate the guide wire distal
end through the foramen of the sacrum and enabling visualization of
the depth of insertion of the dilator over the guide wire.
51. The kit as in claim 46, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
52. The kit as in claim 46, wherein the dilator sheath diameter is
in the range from about 0.33 mm to about 4.00 mm.
53. The kit as in claim 46, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
54. The kit as in claim 46, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
55. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter extending from the lead body
proximal end and lead body distal end, the lead body further
enclosing at least one electrical conductor extending between at
least one proximally located electrical connector adapted to be
coupled to an electrical stimulation pulse generator and at least
one distally located stimulation electrode adapted to apply
electrical stimulation to a sacral nerve, the kit comprising: a
needle having a needle diameter and needle length extending from a
needle distal end capable of penetrating body tissue and a needle
proximal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; and a dilator formed
of a dilator body and a dilator sheath, the dilator body having a
dilator body diameter, a dilator body length extending between a
dilator proximal end and a dilator distal end, and a dilator body
lumen extending from the dilator proximal end to the dilator distal
end, the dilator sheath having a dilator sheath diameter, a dilator
sheath length extending between a dilator sheath proximal end and a
dilator sheath distal end, and a dilator sheath lumen extending
from the dilator sheath proximal end to the dilator sheath distal
end, the dilator sheath lumen having a dilator sheath lumen
diameter sized in operative relation to the dilator body diameter
to selectively receive the dilator body therein to assemble the
dilator, the dilator body lumen having a dilator body lumen
diameter sized in operative relation to the needle diameter to
advance the dilator over the needle proximal end and distally over
the needle through the insertion path to dilate the insertion path
to the dilator sheath diameter and to allow the needle to be
withdrawn through the dilator body lumen, the dilator sheath lumen
diameter sized in operative relation to the lead body to allow the
stimulation lead to be advanced through the dilator sheath lumen to
locate the stimulation lead electrode in operative relation to the
sacral nerve and to allow the dilator sheath to be withdrawn over
the stimulation lead body.
56. The kit as in claim 55, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
57. The kit as in claim 55, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode end and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
58. The kit as in claim 57, wherein the needle body is marked by
depth marks enabling visualization of the depth of insertion of the
needle through the insertion path and the depth of insertion of the
dilator over the needle body.
59. The kit as in claim 55, wherein the needle comprises a needle
body marked by depth marks enabling visualization of the depth of
insertion of the needle through the insertion path and the depth of
insertion of the dilator over the needle body.
60. The kit as in claim 55, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
61. The kit as in claim 55, wherein the dilator sheath diameter is
in the range from about 0.33 mm to about 4.00 mm.
62. The kit as in claim 55, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
63. The kit as in claim 55, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
64. A surgical instrumentation kit for minimally invasive
implantation of a sacral stimulation lead through a foramen of the
sacrum in a patient to electrically stimulate a sacral nerve, the
sacral stimulation lead of the type having a lead body extending
between a lead body proximal end and a lead body distal end, the
lead body having a lead body diameter and enclosing at least one
electrical conductor extending between at least at least one
proximally located electrical connector adapted to be coupled to an
electrical stimulation pulse generator and at least one distally
located stimulation electrode adapted to apply electrical
stimulation to a sacral nerve, the kit comprising: a needle having
a needle diameter, a needle length extending from a needle distal
end capable of penetrating body tissue and a needle proximal end,
and a needle lumen extending from the needle proximal end and
needle distal end, the needle adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin; and a guide wire
having a guide wire diameter sized to fit through the needle lumen
and the stimulation lead lumen and a guide wire length extending
between a guide wire proximal end and a guide wire distal end to
enable insertion of the guide wire through the needle lumen to
locate a distal portion of the guide wire through the foramen of
the sacrum and to enable withdrawal of the needle over the guide
wire; and a dilator formed of a dilator body and a dilator sheath,
the dilator body having a dilator body diameter, a dilator body
length extending between a dilator proximal end and a dilator
distal end, and a dilator body lumen extending from the dilator
proximal end to the dilator distal end, the dilator sheath having a
dilator sheath diameter, a dilator sheath length extending between
a dilator sheath proximal end and a dilator sheath distal end, and
a dilator sheath lumen extending from the dilator sheath proximal
end to the dilator sheath distal end, the dilator sheath lumen
having a dilator sheath lumen diameter sized in operative relation
to the dilator body diameter to selectively receive the dilator
body therein to assemble the dilator body and dilator sheath as the
dilator, the dilator body lumen having a dilator body lumen
diameter sized in operative relation to the guide wire diameter to
advance the dilator over the guide wire proximal end and distally
over the guide wire through the insertion path to dilate the
insertion path to the dilator sheath diameter and to allow the
guide wire to be withdrawn through the dilator body lumen, the
dilator sheath lumen diameter sized in operative relation to the
lead body to allow the stimulation lead to be advanced through the
dilator sheath lumen to locate the stimulation lead electrode in
operative relation to the sacral nerve and to allow the dilator
sheath to be withdrawn over the stimulation lead body.
65. The kit as in claim 64, further comprising: means for creating
an incision through the entry point of the epidermis to a fascia
layer; means for anchoring the stimulation lead to the fascia layer
upon withdrawal of the dilator over the stimulation lead electrode;
and means for closing the incision.
66. The kit as in claim 64, wherein the needle further comprises an
electrically conductive needle body providing a distal electrical
stimulation electrode end and a proximal electrical connector, the
needle body electrically insulated in a region grasped by the
medical clinician between the electrical stimulation electrode and
electrical connector, whereby the distal needle body location in
relation to a sacral nerve can be assessed by delivering electrical
stimulation through the needle to evoke a patient response
signifying the distal needle body location.
67. The kit as in claim 66, wherein the needle body is marked by
depth marks enabling visualization of the depth of insertion of the
needle through the insertion path.
68. The kit as in claim 64, wherein the guide wire is marked by
depth marks enabling visualization of the depth of insertion of the
guide wire through the needle lumen to locate the guide wire distal
end through the foramen of the sacrum and enabling visualization of
the depth of insertion of the dilator over the guide wire.
69. The kit as in claim 64, wherein the needle diameter is in the
range from about 0.46 mm to about 2.80 mm.
70. The kit as in claim 64, wherein the dilator sheath diameter is
in the range from about 0.33 mm to about 4.00 mm.
71. The kit as in claim 64, wherein the needle is selected from the
group consisting of a needle without a hub, a needle with a
removable hub, a solid rod with a sharp tip, and a foramen needle
modified to have an extended length.
72. The kit as in claim 64, further comprising an anchor selected
from the group consisting of a suture anchor and a twist-lock
suture anchor for anchoring the stimulation lead to the fascia
layer upon withdrawal of the dilator over the stimulation lead
body.
Description
[0001] This is a continuation-in-part of U.S. patent application
Ser. No. 09/713,598 filed Nov. 15, 2000 for MINIMALLY INVASIVE
METHOD FOR IMPLANTING A SACRAL STIMULATION LEAD.
CROSS REFERENCE
[0002] This disclosure is related to the following co-pending
application entitled "Minimally Invasive Surgical Techniques For
Implanting Devices That Deliver Stimulation To The Nervous System"
by inventors Gerber et al. (application Ser. No. 09/489,544; filed
Jan. 31, 2000), which is not admitted as prior art with respect to
the present disclosure by its mention in this cross-reference
section.
BACKGROUND OF THE INVENTION
[0003] This disclosure relates to apparatus in the form of a kit of
medical instruments used for surgically implanting an electric
neurostimulation lead in the human sacrum.
[0004] The medical device industry produces a wide variety of
electronic and mechanical devices for treating patient medical
conditions. Depending upon the medical condition, medical devices
can be surgically implanted or connected externally to a patient
receiving treatment. Clinicians use medical devices alone or in
combination with drug therapies and surgery to treat patient
medical conditions. For some medical conditions, medical devices
provide the best, and sometimes the only, therapy to restore an
individual to a more healthful condition and a fuller life.
Conditions that medical devices can effectively treat include
pelvic floor disorders.
[0005] Pelvic floor disorders adversely affect the health and
quality of life of millions of people. Pelvic floor disorders
include urinary control disorders such as urge incontinency, urge
frequency, voiding efficiency, fecal control disorders, sexual
dysfunction, and pelvic pain. Individuals with urinary control
disorders often face debilitating challenges in their everyday
lives. These individuals can be preoccupied with trips to the
bathroom, fears of embarrassment, and sleepless nights. Some
suffers become so anxious that they become isolated and depressed.
Pelvic floor disorders can be treated with a variety of therapeutic
options such as behavior modification including biofeedback,
pharmacological treatment, mechanical intervention such as
self-catheterization, physical appliances such as diapers, and
surgical intervention. Surgical treatments are the most invasive
and are often considered after other therapies have proven
ineffective.
[0006] One surgical technique to treat urinary control disorders is
the implantable InterStim.RTM. therapy, available from Medtronic,
Inc., which applies mild electrical stimulation to the sacral
nerves in the lower region of the spine to influence behavior of
structures such as the bladder, sphincter and pelvic floor muscles.
Generally, implantation of InterStim therapy involves surgically
implanting a stimulation lead near the sacral nerves. The
stimulation lead is a very small, insulated electrical conductor
with electrical stimulation contacts on the distal end placed near
the sacral nerves and an electrical connector on the opposite
proximal end of the lead. The lead electrical connector is
typically connected to a small extension, and the extension is
connected to a small neurostimulator that operates similar to a
cardiac pacemaker by delivering occasional small electrical pulses
that sometimes create a tingling sensation felt by the patient. The
stimulation lead, lead extension, and neurostimulator are all
implanted in the patient in a manner that is typically not
perceptible by others. InterStim therapy can improve the condition
of a pelvic floor disorder patient and allow the patient to lead a
full life. Also, InterStim therapy is nondestructive and
reversible.
[0007] Previous surgical methods and apparatus used to implant a
neurostimulation lead in a patient's sacrum to treat pelvic floor
disorders have been invasive by requiring a large sacral incision
in a procedure known as dissection. FIG. 1a (prior art) shows a
sacral dissection. Dissection involves making a midline incision
over the sacrum from a little below S4 up to S1 that in an adult
ranges from about 7.62 cm (3.0 inches) to 12.7 cm (5.0 inches).
After the incision is made, the fascia lateral to the midline is
cleaned off and divided in the direction of the incision
approximately one finger width lateral to the midline. Next, the
paraspinal muscle fibers are split and sharply retracted. Once the
muscle fibers are retracted, the sacral foramen is exposed while
preserving the periosteum. Next, the desired foramen is located by
observing anatomical landmarks and palpating for a
marble-board-like depression in the posterior sacral surface. FIG.
1b (prior art) shows a foramen dissection. Once the desired foramen
is located, another small incision is made over the desired foramen
that is large enough to allow insertion of the stimulation lead.
The stimulation lead is inserted through the incision. Surgically
implanting the stimulation lead in this manner near the patient's
sacral nerve can cause patient complications, create significant
patient's recovery time, and create a significant expense to the
healthcare system. An example of the previous surgical method to
implant a neurostimulation lead is described in Medtronic,
"InterStim.RTM. Therapy Sacral Nerve Stimulation For Urinary
Control Therapy Reference Guide," Section 5 InterStim Device
Implantation Procedure, pp. 51-52 (1999).
[0008] For the foregoing reasons, there is a need for a less
invasive surgical instrument set for performing a method of
implanting a neurostimulation lead in a patient through a foramen
of the sacrum in relation to a sacral nerve, whereby patient
surgical complications, surgical recovery time, and surgical costs
are reduced while maintaining the substantial patient benefits of
neurostimulation of the sacral nerve.
SUMMARY OF THE INVENTION
[0009] The minimally invasive instrument set for implanting sacral
stimulation leads comprises at least a needle and a dilator that
are particularly adapted to enable introduction of a
neurostimulation lead into a foramen to locate a distal
neurostimulation lead electrode(s) in operative relation to a
sacral nerve. The needle is adapted to be grasped by a medical
clinician with the needle distal end directed toward and inserted
through an entry point of the skin or a skin incision posterior to
the sacrum and guided along an insertion path into a foramen to
locate at least a distal portion of the needle extending alongside
a sacral nerve and a proximal portion of the needle extending from
the entry point away from the patient's skin. The dilator is
adapted to be inserted over the needle proximal end to locate the
needle within the dilator body lumen and to be advanced distally
over the needle through the insertion path to dilate the insertion
path to the dilator diameter. The needle is adapted to be withdrawn
through the dilator body lumen so that the stimulation lead can be
advanced through the dilator body lumen to locate the stimulation
lead electrode into operative relation to the sacral nerve. The
dilator is adapted to be withdrawn over the stimulation lead
body.
[0010] Alternatively, the minimally invasive instrument set
comprises a needle having a needle lumen, a dilator and a guide
wire that are particularly adapted to enable introduction of a
neurostimulation lead into a foramen. The guide wire has a guide
wire diameter sized to fit through the needle lumen and a guide
wire length extending between a guide wire proximal end and a guide
wire distal end. The guide wire is adapted to be inserted through
the needle lumen to locate a distal portion of the guide wire
through the foramen of the sacrum after the needle is guided into
position. The needle is adapted to be withdrawn over the guide
wire, and the dilator is adapted to be inserted over the guide wire
proximal end to locate the guide wire within the dilator body lumen
and to be advanced distally over the guide wire through the
insertion path to dilate the insertion path to the dilator
diameter. The guide wire is adapted to be withdrawn through the
dilator body lumen, the stimulation lead is adapted to be advanced
through the dilator body lumen to locate the stimulation lead
electrode into operative relation to the sacral nerve, and the
dilator is adapted to be withdrawn over the stimulation lead
body.
[0011] In a further preferred embodiment, the dilator comprises the
assembly of a dilator body and a dilator sheath that are inserted
through the skin as an assembly and are separated to enable
introduction of the neurostimulation lead through the dilator
sheath lumen. The dilator is adapted to be introduced over the
needle or guide wire as above described, whereupon the dilator body
and guide wire are withdrawn, leaving the dilator sheath. The
stimulation lead is adapted to be advanced through the dilator body
lumen to locate the stimulation lead electrode into operative
relation to the sacral nerve, and the dilator sheath is adapted to
be withdrawn over the stimulation lead body.
[0012] The needle, dilator and guide wire are all preferably formed
of a conductive material insulated along the exposed lengths
thereof but exposed at or along the proximal and distal ends
thereof so as to be capable of being used to conduct test
stimulation to the sacral nerve to assess the efficacy of
stimulation prior to implantation of the neurostimulation lead and
to establish the depth of positioning of the neurostimulation lead
electrode.
[0013] The needle, dilator, guide wire and neurostimulation lead
bodies are marked with depth indicators that are correlated to one
another so that the depth of insertion from the skin of each is
ascertainable from the exposed marking so as to assure that the
clinician extends each instrument to the same depth to properly
locate the neurostimulation lead electrode in operative relation to
the sacral nerve.
[0014] The guide wire may be relatively stiff to prevent bending or
flexible to enable a degree of bending.
[0015] Additionally if the clinician desires to separately anchor
the stimulation lead, an incision can be created through the entry
point from an epidermis to a fascia layer. The stimulation lead is
anchored to the fascia layer. Finally, the incision is closed. The
minimally invasive instrumentation set and method of sacral
stimulation lead implantation can be practiced in a wide variety of
embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1a shows a prior art sacral dissection; FIG. 1b shows a
prior art foramen dissection;
[0017] FIG. 1c shows an environment of a patient undergoing a
sacral stimulation procedure;
[0018] FIG. 2 shows an embodiment of an implanted
neurostimulator;
[0019] FIGS. 3a-3g show some surgical tools that can be used to
perform the minimally invasive method;
[0020] FIG. 4 shows a flowchart of a first minimally invasive
method embodiment;
[0021] FIG. 5a shows a flowchart of a second minimally invasive
method embodiment;
[0022] FIG. 5b shows a needle being inserted into a foramen
embodiment;
[0023] FIG. 5c shows a cross section view of FIG. 5b;
[0024] FIG. 5d shows the needle being used as a guide for a larger
needle embodiment;
[0025] FIG. 5e shows removal of a stylet and insertion of a
stimulation lead embodiment;
[0026] FIG. 5f shows another view of insertion of the stimulation
lead embodiment;
[0027] FIG. 5g shows removal of the needle and insertion of an
anchor embodiment;
[0028] FIG. 5h shows fixation of the anchor embodiment;
[0029] FIG. 5i shows another stimulation lead fixation
embodiment;
[0030] FIG. 5j shows another view of the stimulation lead fixation
embodiment shown in the FIG. 5i embodiment;
[0031] FIG. 5k shows an anchored stimulation lead that is tunneled
for connection to a medical device;
[0032] FIG. 6a shows a flowchart of a third minimally invasive
method embodiment;
[0033] FIG. 6b shows a patient having a needle inserted posterior
to the patient sacrum embodiment;
[0034] FIG. 6c shows an anatomical drawing of the needle inserted
as shown in the FIG. 6b embodiment;
[0035] FIG. 6d shows a patient having a guide wire inserted through
the needle;
[0036] FIG. 6e shows an anatomical drawing of the guide wire
inserted as shown in the FIG. 6d embodiment;
[0037] FIG. 6f shows a patient having a dilator placed over the
guide wire embodiment;
[0038] FIG. 6g shows an anatomical drawing of the dilator placed
over the guide wire as shown in the FIG. 6f embodiment;
[0039] FIG. 6h shows a patient having the dilator inserted into the
sacrum embodiment;
[0040] FIG. 6i shows an anatomical drawing of the dilator inserted
into the sacrum as shown in the FIG. 6h embodiment;
[0041] FIG. 6j shows preparation for inserting the stimulation lead
into the dilator embodiment;
[0042] FIG. 6k shows inserting the stimulation lead into the
dilator embodiment;
[0043] FIG. 6l shows removal of the dilator embodiment;
[0044] FIG. 6m shows creating an incision at the stimulation lead
insertion site embodiment;
[0045] FIG. 6n shows marking the stimulation lead embodiment;
[0046] FIG. 6o shows an anatomical cross-section drawing of marking
the stimulation lead embodiment;
[0047] FIG. 6p shows applying a lead anchor to the stimulation lead
embodiment;
[0048] FIG. 6q shows tunneling the stimulation lead embodiment;
[0049] FIG. 6r shows fixation of the lead anchor to the lead body
embodiment;
[0050] FIG. 6s shows fixation of the lead anchor to fascia of the
patient embodiment;
[0051] FIG. 7a shows a flowchart of a fourth minimally invasive
embodiment;
[0052] FIG. 7b shows an anatomical cross-section of creating an
incision and inserting the needle embodiment;
[0053] FIG. 7c shows an anatomical cross-section of insertion of
the guide embodiment;
[0054] FIG. 7d shows an anatomical cross-section of the guide in
place after the needle has been removed embodiment;
[0055] FIG. 7e shows an anatomical cross-section of placement of
the stimulation lead over the guide embodiment;
[0056] FIG. 7f shows an anatomical cross-section of fixing the
stimulation lead to a patient's fascia and removal of the guide
embodiment;
[0057] FIG. 7g shows an anatomical cross-section of closing the
incision and tunneling the stimulation lead embodiment;
[0058] FIGS. 8a-8c shows a variation of the dilator of FIG. 3e
usable in any of the procedures described herein comprising a
dilator formed of the assembly of a dilator body and a dilator
sheath;
[0059] FIG. 8e shows a needle or foramen needle having a hub and
depth marks along the needle body;
[0060] FIG. 8f shows a needle or foramen needle without a hub and
with depth marks along the needle body;
[0061] FIG. 8g shows a guide wire having depth marks along its
length;
[0062] FIG. 9a shows a flowchart of a fifth minimally invasive
method embodiment employing the dilator of FIGS. 8a-8c along with
the needle of FIGS. 3a or 3d;
[0063] FIG. 9b shows inserting and guiding a needle, e.g., a
foramen needle, comprising a hollow needle body and an obturator
within the needle body lumen to the sacral nerve site;
[0064] FIG. 9c shows inserting and advancing a guide wire through
the needle body lumen after electrical testing and removal of the
obturator from the needle body lumen;
[0065] FIG. 9d shows advancing the dilator of FIG. 8c over the
guide wire to locate the distal end of the guide wire at the sacral
nerve and then withdrawing the guide wire from the dilator body
lumen;
[0066] FIG. 9e shows withdrawal of the dilator body from the
dilator sheath;
[0067] FIG. 9f shows advancing a neurostimulation lead through the
dilator sheath lumen to locate the distal neurostimulation
electrodes into the foramen and into operative relation with the
sacral nerve;
[0068] FIG. 9g shows withdrawal of the dilator sheath over the
stimulation lead body after electrical testing of the stimulation
efficacy; and
[0069] FIG. 10 shows a flowchart of a sixth minimally invasive
method embodiment employing the dilator of FIGS. 8a-8c along with
the needle of FIGS. 3a or 3d.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0070] FIG. 1c shows an environmental view of a sterile area in
which the minimally invasive method for implanting a sacral
stimulation lead can be performed. The method can be performed in a
wide variety of locations 20 that have a sterile field and common
medical instruments such as an operating room, surgery center. The
method and its many embodiments are typically performed by a
urologist 22, but can be performed by many clinicians 22 trained in
stimulation lead implantation. The patient 24 is placed under local
or general anesthesia. With local anesthesia, the method can
potentially be performed in a clinician's 22 office for greater
accessibility and reduced costs. A sacral stimulation lead can be
implanted for a variety a purposes such as to treat pelvic floor
disorders. Pelvic floor disorders include urinary control
disorders, fecal control disorders, sexual dysfunction, and pelvic
pain.
[0071] FIG. 2 shows an embodiment of an implanted neurostimulator
26 to stimulate sacral nerves 27 located near the sacrum 28. The
sacral nerves are assessable through an entry point 29 along an
insertion path 33 into a foramen 31 to reach a desired location 35.
A neurostimulation system can include a stimulation lead 30, a lead
anchor (FIG. 3g), a lead extension 32, a trial stimulator (not
shown), an implantable neurostimulator 26, a physician programmer
(not shown), and a patient programmer (not shown). The stimulation
lead 30 has electrical contacts 34 positioned on the distal end to
stimulate nerves and connectors (not shown) on the proximal end to
connect to a lead extension or directly to the trial
neurostimulator or implantable neurostimulator 26. The stimulation
lead 30 can be a Medtronic Model 3886 quadrapolar lead without
anchor having a diameter of approximately a 0.127 cm (0.050 inch)
and designed to accept a stylet through the center of the
stimulation lead 30 to assist in insertion. The lead anchor (FIG.
3f) fixes the stimulation lead 30 to prevent the stimulation lead
30 from migrating away from the position selected by the implanting
clinician 22. The lead extension 32 connects between the
stimulation lead 30 and the trial stimulator or implantable
stimulator 26. The trial neurostimulator tests the effectiveness of
stimulation to treat the patient's condition prior to implantation
of an implantable neurostimulator 26.
[0072] The implantable neurostimulator 26 provides a programmable
stimulation signal that is delivered to a desired location or
target to stimulate selected nerves. The implantable
neurostimulator 26 is typically implanted in a subcutaneous pocket
around the upper buttocks sometime after the stimulation lead 30
has been implanted and its effectiveness verified. The physician
programmer is used by the clinician 22 to communicate with the
implantable neurostimulator 26 to program the stimulation signal
produced by the implantable neurostimulator. The patient programmer
allows the patient to communicate with the implantable
neurostimulator to control certain parameters of the stimulation
signal typically selected by a clinician. With a pelvic floor
disorder, a patient can typically control stimulation signal
parameters such as voltage amplitude. Neurostimulation systems with
the components discussed above are available from Medtronic, Inc.
in Minneapolis, Minn.
[0073] FIGS. 3a-3g show some of the surgical instruments (not to
scale) typically available to the implanting clinician to aid in
implanting the stimulation lead 30, the instruments selected to
form instrument kits of he present invention. Local anesthetic is
delivered to the patient typically with a syringe such as a Luer
Slip Disposable 12 cc syringe (not shown). The needle 36 is
selected based upon the needs of the patient 24 typically ranging
in size from an outer diameter of about 26 gauge (0.46 mm) to about
12 gauge (2.80 mm) such as the 20 gauge (0.89 mm), thin wall,
foramen needle 38 Models 041828 and 041829 available from
Medtronic. The foramen needle 38 has a stylet 40, also known as an
obturator, in the foramen needle 38 central opening and markings
that measure 1.0 cm increments and a wider mark at 5.0 cm to aid in
positioning needle depth. Additionally the foramen needle 38 tip
and proximal portion adjacent to the hub are conductive, so a trial
stimulator can be electrically connected to the hub. The trial
stimulator stimulation signal will travel to the foramen needle 38
tip to evoke a response from the patient 24 to determine if the
foramen needle 38 is properly position and whether the patient 24
will likely benefit from stimulation.
[0074] The dilators 42 can be metal or plastic dilators typically
ranging in size from an outer diameter of about 5 French (0.33 mm)
to about 14 French (4.00 mm), such as an Angiocath.RTM. intravenous
catheter placement unit available from Parke Davis & Company,
selected based upon the size of stimulation lead 30 to be
implanted. Multiple dilators 42 can be used typically in sequence
from a smaller diameter to a larger diameter to achieve the desired
dilation while controlling tissue trauma. The guide wire 44 is
typically a thin biocompatible stainless steel wire with a diameter
such as 0.076 cm (0.030 inch). Dilators 42 and guide wires 44 are
available in cardiac pacing lead introducer kits such as
Medtronic's Model 3208, Percutaneous Lead Introducer. The dilator
42 can be a metal or plastic dilator sized appropriately to pass
the stimulation lead 30 such as an 8 French (2.6 mm) sized dilator.
The neurostimulation lead anchor 46 shown in FIG. 3g over
stimulation lead 30 is an implantable surgical anchor configured to
fix to the stimulation lead 30 such as a suture anchor or a
twist-lock anchor available in the Medtronic Model 3550-1 Boots and
Anchors Accessory Kit or the silicone anchor included in the
Medtronic Model 3886 Lead Electrode Kit. Additionally to assist the
clinician 22 in guiding placement of the needle 36 and guide wire
44, the clinician 22 may use a fluoroscope or x-ray machine.
[0075] First Minimally Invasive Method Embodiment
[0076] FIG. 4 shows a flowchart of a first embodiment of the
minimally invasive implantation method employing a first instrument
kit of the present invention. FIG. 2 shows an embodiment of an
implanted neurostimulator 26 to stimulate sacral nerves 27, and
FIGS. 3a-3g show some surgical tools that can be used to perform
the minimally invasive method. Prior to beginning the first method
for minimally invasive method embodiment 48 for sacral electrical
stimulation lead 30 implantation in a patient 24, the following
preparatory actions are typically taken. A local anesthetic is
typically applied to anesthetize the area where the stimulation
lead 30 will be implanted such as posterior to the sacrum 28. Since
embodiments of the method permit use of a local anesthetic,
patients 24 can be treated on an outpatient basis to greatly
reduces costs over inpatient care and reduce recovery time. This
significant cost reduction also makes sacral stimulation lead 30
implantation and its many beneficial therapies available to more
patients 24 because healthcare payers are more likely to cover
procedure costs. Also by using local anesthesia, the implanting
clinician 22 can use the patient's 24 conscious sensory response to
stimuli such as trial stimulation to aid in placing the stimulation
lead 30. By using the patient's 24 conscious sensory response
during stimulation lead 30 placement, the stimulation lead 30 can
be more accurately placed reducing the potential for an ineffective
therapy and reducing the potential for patient 24 injury caused by
a misplaced lead 30. Other forms of anesthesia can also be used
such as general anesthesia. Once the patient 24 has been
anesthetized, the first method embodiment 48 can begin.
[0077] A needle 36 is inserted 50 posterior to the sacrum 28
through an entry point 29 typically created with the needle 36. The
needle 36 can take a variety of forms such as a needle without a
hub (cannula), a solid rod with a sharp tip, a needle with a hub
that can be removed for example by a cutting tool, or a foramen
needle 38 modified to have an extended length and a hub that can be
removed with a cutting tool. The entry point 29 is typically a
percutaneous entry created when the needle 36 is inserted. The
needle 36 is hand guided 52 into the foramen 31 along an insertion
path 33 to a desired location 35. The foramen's 31 approximate
location can be found using anatomical landmarks, fluoroscopy, or
x-rays. When guiding 52 the needle 36, the position of the needle
36 can be sensed by a variety of means such as by applying an
electrical signal to the needle 36 to evoke a patient 24 response
such as a motor or sensory response. Once the needle 36 is in
position, the needle 36 can remain in the position to serve as a
guide for the dilator 42, or in the alternative a guide wire 44 can
be inserted through the needle 36. When the needle 36 is used as a
guide for the dilator 42, the needle hub 45 typically must be
removed before the dilator 42 can be guided over the needle 36.
Alternatively, a guide wire 44 can be used as the guide for the
dilator 42. The guide wire 44 can be a flexible guide wire, a stiff
guide wire, or a stylet. Once the guide wire 44 is in position, the
needle 36 can be removed, and the guide wire 44 can serve as a
guide for the dilator 42.
[0078] The insertion path 33 is dilated 54 with a dilator 42 to a
diameter sufficient for inserting a stimulation lead 30. The needle
36 is removed 56 from the insertion path 33, or alternatively the
guide wire 44 is removed 56 from the insertion path 33. When
removing 56 the needle 36 from the insertion path 33, care should
be taken to avoid displacing the dilator 42. The stimulation lead
30 is inserted 58 to the desired location 35. Since the chronic
stimulation lead 30 is being inserted 58 directly without the
requirement for a separate test stimulation lead (not shown), such
as a Medtronic Test Simulation Lead Model 3057, the chronic
stimulation lead 30 can be placed without positioning repeatability
variation. Also, there is a greater correlation between acute test
stimulation and chronic therapy stimulation because the same lead
30 is performing both test stimulation and therapy stimulation. The
desired location 35 can be any area of the sacrum 28 intended to
achieve a therapeutic effect such as into the foremen 31. One way
to verify the stimulation lead's 30 position is to apply an
electrical signal to the stimulation lead 30 to evoke a patient 24
motor or sensory response. Other ways to verify the stimulation
lead's 30 position include imaging techniques such as fluoroscopy
and x-ray. When inserting 58 the implantable stimulation lead 30,
the lead 30 is advanced through the dilator 42 to the desired
location 35 for stimulation. The dilator 42 is removed 60 from the
insertion path 33. When removing 60 the dilator 42 from the
insertion path 33, care should be taken to avoid displacing the
stimulation lead 30. Additionally, stimulation lead 30 position
should be re-verified by one of the previously discussed
techniques. Once the dilator 42 is removed, the clinician 22 may
decide that the lead 30 does not need to be fixed because the
patient's 24 physiology itself adequately stabilizes the lead 30.
When the stimulation lead 30 is not separately fixed, patient 24
tissue disruption is minimized which provides for faster patient 24
recovery and potentially less stimulation lead 30 migration caused
by disrupted tissue changes. If the clinician 22 does not wish to
separately fix the stimulation lead 30, the first method embodiment
48 is completed. Optionally, the clinician 22 can separately fix
the stimulation lead 30 by creating an incision 62, anchoring the
lead 64, and closing the incision 66.
[0079] FIG. 5h shows an embodiment for separately fixing the
stimulation lead. To separately fix the stimulation lead 30, an
incision 68 through the entry point 29 is created from an epidermis
70 to a fascia layer 72 such as the lumbosacral fascia layer. This
incision 68 can also be created at a later point in the method
embodiment 48 without adversely affecting the method. The
stimulation lead 30 is anchored 64 to the fascia layer 72. When
anchoring 64 the stimulation lead 64 care is again should be taken
to avoid displacing the stimulation lead 30. Finally, the incision
68 created for the anchor is closed 66. Since the first method
embodiment 48 disrupts less tissue than the prior art method,
patient 24 tissue disruption is minimized which provides for faster
patient recovery and potentially less stimulation lead 30 migration
caused by disrupted tissue changes.
[0080] A portion of the first minimally invasive method embodiment
48 can also be used simply for stimulation lead 30 placement for
acute test stimulation rather than implantation. For stimulation
lead 30 placement, typically the same procedure is used as for
implantation through removing the dilator 60 from the insertion
path 33. Once the dilator 42 is removed, stimulation lead 30
placement is validated to ensure the stimulation lead 30 is in the
desired location 35.
[0081] Second Minimally Invasive Method Embodiment
[0082] FIG. 5a shows a flowchart of a second minimally invasive
implantation method embodiment 74, and FIGS. 5b-5k show various
implementation element embodiments. The second minimally invasive
method embodiment 74 is similar to the first minimally invasive
method embodiment 48 with the exception that in the second method
embodiment 74 includes an incision for anchoring that is created 62
after the needle has been guided 52 to a desired location 35 that
is optional in the first method embodiment 48. By making the
incision 62 earlier than optionally performed in the first
minimally invasive method 48, the stimulation lead 30 can be more
easily anchored 64 to a fascial layer 72 such as the lumbosacral
fascia layer closer to the stimulation lead 30 distal end.
[0083] A portion of the second minimally invasive method embodiment
74 can also be used simply for stimulation lead 30 placement for
acute test stimulation rather than implantation. For stimulation
lead 30 placement, typically the same procedure is used as for
implantation through removing the dilator 60 from the insertion
path 33. Once the dilator is removed 60, stimulation lead 30
placement is validated to ensure the stimulation lead 30 is in the
desired location 35.
[0084] Third Minimally Invasive Method Embodiment
[0085] FIG. 6a shows a flowchart of a third minimally invasive
implantation method embodiment 76, and FIGS. 6b-6o show various
implementation element embodiments. The third minimally invasive
method embodiment 76 is similar to the first minimally invasive
method embodiment 48 with the exception that a guide wire 44,
stylet, or long needle is inserted 78 to guide the dilator 42 and
the guide wire 44 is removed 80 after dilation has been completed.
More specifically, after the needle 36 has been guided 52 into the
foramen along an insertion path 33 to a desired location 35, a
guide wire 44 is inserted into the needle 36 to the desired
location 35. Once the guide wire 44 is in place, the needle 36 is
removed 56 while retaining the guide wire 44 at the desired
location 35. The dilator 42 is placed over the guide wire 44 along
the insertion path 33 to dilate 54 the insertion path 33 to a
diameter sufficient for inserting 58 a stimulation lead 30. Once
the dilator 42 is in place, the guide wire 44 is removed 80 from
the dilator 42. After the stimulation lead 30 is in the desired
location 35, the dilator 42 is removed 60. With the third minimally
invasive method 76, once the dilator 42 is removed 60, the
additional steps of creating an incision 62, anchoring the lead 64,
and closing the incision 66 are optional. Once the dilator 42 is
removed 60, the clinician 22 may decide that the stimulation lead
30 does not need to be fixed because the patient's 24 physiology
itself adequately stabilizes the stimulation lead 30. If the
clinician 22 determines the patient 24 requires the stimulation
lead 30 fixation, then the clinician 22 would perform the elements
of creating an incision 62, anchoring the lead 64, and closing the
incision 66 as discussed previously.
[0086] A portion of the third minimally invasive method embodiment
76 can also be used simply for stimulation lead 30 placement for
acute test stimulation rather than implantation. For stimulation
lead 30 placement, typically the same procedure is used as for
implantation through removing 60 the dilator 42 from the insertion
path. Once the dilator 42 is removed 60, stimulation lead 30
placement is validated to ensure the stimulation lead 30 is in the
desired location 35.
[0087] Fourth Minimally Invasive Method Embodiment
[0088] FIG. 7a shows a flowchart of a fourth minimally invasive
implantation method embodiment 82, and FIGS. 7b-7g show various
implementation element embodiments. The fourth minimally invasive
method embodiment 82 is similar to the second minimally invasive
method embodiment 74 with the exception that a guide wire 44 or
stylet is inserted 78 to guide the stimulation lead 30 and the
stimulation lead 30 functions as the dilator 42, so a separate
dilator 42 is not used. More specifically, after the incision 68 is
created 62, a guide wire 44 is inserted 78 into the needle. Once
the guide wire 44 is in the desired location 35, the needle 36 is
removed 56 from the insertion path 33. In one embodiment, the
stimulation lead 30 is configured with a centrally located stylet
lumen and a pointed tip, so the stimulation lead 30 can serve as
the dilator 42. The stimulation lead 30 stylet lumen is inserted 58
over the guide wire 44 and the stimulation lead 30 is advanced to
the desired location 35. After the stimulation lead 30 is in the
desired location 35, the guide wire 44 is removed 80 from the
stimulation lead 30. Then the stimulation lead 30 is anchored 64
and the incision 68 is closed 66 similar to the second minimally
invasive method embodiment 74.
[0089] A portion of the fourth minimally invasive method embodiment
82 can also be used simply for stimulation lead 30 placement for
acute test stimulation rather than implantation. For stimulation
lead 30 placement, typically the same procedure is used as for
implantation through removing 80 the guide wire 44 from the
stimulation lead 30. Once the guide wire 44 is removed, stimulation
lead 30 placement is validated to ensure the stimulation lead 30 is
in the desired location 35.
[0090] Fifth and Sixth Minimally Invasive Method Embodiments
[0091] The above described instrument kits used in the first
through fourth embodiments are modified by substitution of a
dilator 42' formed of the assembly of a dilator body 47 and a
dilator sheath 49 as shown in FIGS. 8a-8c. The dilator body 47 is
preferably conductive, and the dilator sheath 49 is preferably
non-conductive but may bear radiopaque and visually observable
depth marks 51 along its length to facilitate radiographic imaging
when it is extended into the patient's body. The depth markings or
marks 51 can be one centimeter or one-half centimeter bands or
numerals or other indicia that indicate the depth of insertion to
clinician from the exposed marking. The most distal mark is spaced
from the distal tip of dilator sheath 49 to indicate a
predetermined depth of the distal tip of the dilator body 47
protruding distally during insertion as shown in FIG. 8c.
[0092] Thus, when assembled as shown in FIG. 8c, the dilator body
distal end extends out of the dilator sheath distal end and is
electrically exposed. Electrical stimulation of the sacral nerve to
test placement can take place through the dilator body 47 while the
dilator sheath 49 is in place
[0093] The dilator body 47 has a dilator body diameter, a dilator
body length extending between a dilator proximal end and a dilator
distal end, and a dilator body lumen extending from the dilator
proximal end to the dilator distal end. The dilator sheath has a
dilator sheath diameter, a dilator sheath length extending between
a dilator sheath proximal end and a dilator sheath distal end. A
dilator sheath lumen extends from the dilator sheath proximal end
to the dilator sheath distal end, the dilator sheath lumen having a
dilator sheath lumen diameter sized in operative relation to the
dilator body diameter to selectively receive the dilator body
therein to assemble the dilator body and dilator sheath as the
dilator as shown in FIG. 8c. The dilator sheath lumen is also sized
in operative relation to the diameter of the neurostimulation lead
body so that the neurostimulation lead can be advanced through the
dilator sheath.
[0094] The needle 36 or foramen needle 38 is also shown in FIG. 8d
with a hub 45 and with depth marks 53 in FIG. 8e and without a hub
and with depth marks 55. The guide wire 44 is also shown in FIG.
8f. marked with further depth marks 57. In addition, the body of
the neurostimulation lead 30 is marked with depth marks. The depth
mark 53' is widened or otherwise made distinguishable to indicat a
particular depth, e.g., 5 cm, to assist the clinician in keeping
track of the marks 53.
[0095] These depth marks 53, 55, 57 are correlated to one another
and to the depth marks 51 so that the depth of insertion from the
skin of each instrument is ascertainable from the proximal exposed
marks. These marks 53, 55, 57 can be observed to maintain the depth
while manipulating the instruments to assure that the clinician
extends each instrument to the same depth. Similarly, the depth
marks on the neurostimulation lead 30 are correlated to the length
of the dilator 42 or the dilator sheath 49 to properly locate a
neurostimulation lead electrode in operative relation to the sacral
nerve. and lead electrode(s)
[0096] For example, one of the depth marks of each set can be
widened or otherwise made distinguishable from the others so that
the clinician can tell when the distal end or distal electrode(s)
of the instrument or lead introduced through the lumen or over an
instrument already placed to the site is properly positioned at the
site. In FIG. 8f, a mark 57' is placed along the guide wire body at
a distance from the distal end that, when exposed from the needle
hub 45 or a dilator hub indicates that the distal end of the guide
wire 44 is positioned at the distal end of the needle 36, 38 or
dilator 42'. Conversely, a dilator 42, 42' or lead 30 is inserted
over the guide wire 44 until the mark 57' is exposed showing that
the distal end of the dilator 42, 42' or lead 30 is properly
advanced over the guide wire 44 to the desired site. Similarly, in
a variation where a dilator 42 or 42' is inserted over the needle
36, 38 depicted in FIG. 8e, a mark 55' placed along the needle body
at a distance from the distal end is exposed from the dilator hub
that signifies that the dilator distal tip is at the desired
site.
[0097] The needle 36, 38, dilator 42' and guide wire 44 are all
preferably formed of a conductive material insulated along the
exposed lengths thereof but exposed at or along the proximal and
distal ends thereof so as to be capable of being used to conduct
test stimulation to the sacral nerve to assess the efficacy of
stimulation prior to implantation of the neurostimulation lead and
to establish the depth of positioning of the neurostimulation lead
electrode. For example, an exposed distal electrode 59 and an
exposed proximal connector element 63 is depicted on needle 36, 38
in FIG. 8e, and an exposed distal electrode 61 and an exposed
proximal connector element 65 is depicted on guide wire 44 in FIG.
8f. The dilator body lumen has a dilator body lumen diameter sized
in operative relation to the diameter of guide wire 44 or needle 36
or 38 so that the assembled dilator can be advanced over the guide
wire 44 in accordance with the method depicted in FIG. 9a or over
the needle 36 or 38 in accordance with the method depicted in FIG.
10.
[0098] FIG. 9a shows a flowchart of a fifth minimally invasive
method embodiment employing the dilator 42' of FIGS. 8a-8c along
with the needle 36 of FIGS. 3a and 8 or foramen needle 38 of FIG.
3d and a guide wire 44. Many of the steps of FIG. 9a are common to
the steps of FIGS. 4, 5a, 6a, and 7a, and commonly enumerated. FIG.
9b shows inserting and guiding a needle 36, e.g., a foramen needle
36, comprising a hollow needle body and a stylet or obdurator 40
within the needle body lumen, to the sacral nerve site in
accordance with steps 50 and 52. The needle 36, 38 is electrically
insulated along its length except along the distal tip and
preferably has depth marks spaced along the needle shaft or body as
described above that the clinician observes while advancing the
needle distal tip to the desired location 35 within or through the
foramen and adjoining the sacral nerve. The proximal end of the
obdurator 40 can be coupled to a neurostimulator to deliver
neurostimulation to test the stimulation efficacy at the location
35.
[0099] FIG. 9c shows inserting and advancing a guide wire 44
through the needle body lumen after electrical testing and removal
of the obdurator 40 from the needle body lumen in accordance with
step 78. The guide wire 44 is advanced until the guide wire marking
57' abuts the needle hub 45 or needle proximal end if a needle 36,
38 of the type depicted in FIG. 8e is employed. FIG. 9c also shows
withdrawal of the needle 36, 38 over the guide wire 44 in
accordance with step 56, leaving the guide wire 44 in place
extending from its distal end at the desired location 35 and its
proximal end projecting from the patient's skin.
[0100] Preferably, the guide wire 44 is stiff and straight and is
long enough so that the dilator 42' can be inserted over the guide
wire 44 outside of the patient's skin. The proximal end of the
guide wire 44 can then be grasped as the dilator 42' is advanced
over and past it. FIG. 9d shows advancing the dilator 42' of FIG.
8c over the guide wire 44 to locate the distal end of the guide
wire 44 at the desired location 35 adjoining the sacral nerve in
accordance with step 90 and then withdrawing the guide wire 44 from
the dilator body lumen in accordance with step 80. Again, the
dilator 42' is advanced distally over the guide wire 44 until the
mark 57' is exposed, which indicates that the dilator body distal
end is at the desired location 35.
[0101] FIG. 9e shows withdrawal of the dilator body 47 from the
dilator sheath 49 in accordance with step 92. The depth marking on
the dilator sheath surface exposed at the skin incision is observed
to ensure that the dilator sheath 49 is not inadvertently advanced
or withdrawn as the dilator body is withdrawn.
[0102] FIG. 9f shows advancing a neurostimulation lead 30 through
the dilator sheath lumen to locate the distal neurostimulation
electrode(s) into the foramen and into operative relation with the
sacral nerve at the desired site 35 in accordance with step 58. The
depth marking on the lead body exposed at the proximal dilator
sheath hub can be employed to ensure that the lead electrode(s) has
exited the dilator sheath distal end but is not advanced too
far.
[0103] FIG. 9g shows withdrawal of the dilator sheath 49 over the
stimulation lead body after electrical testing of the stimulation
efficacy through the lead 30 in accordance with step 94. Then,
steps 62, 64 and 66 can be followed as described above to complete
the implantation of the neurostimulation lead and implantable
neurostimulator. As noted above, step 62 of forming the incision
can optionally be performed between steps 52 and 78. Or, step 62
can be performed while the dilator sheath 49 is in place after step
92 or step 58 or FIG. 9a.
[0104] FIG. 10 shows a flowchart of a sixth minimally invasive
method embodiment employing the dilator 42' of FIGS. 8a-8c along
with the needle 36 of FIG. 3a or the foramen needle 38 of FIG. 3d.
In this variation, the guide wire 44 is not employed, and needle
36, 38 is either not provided with a hub 45 or the hub 45 is cut
off after step 52. The assembled dilator 42' is inserted over the
needle 36, 38, in step 90', and the needle is withdrawn in step 56.
The remaining steps of FIG. 10 are common with those of FIG. 9a
using the instruments as shown in the related illustrations of
FIGS. 9b-9g as described above.
[0105] Thus, embodiments of a minimally invasive sacral lead
implantation instrumentation kits are disclosed with many benefits.
Embodiments of the instrumentation kits can reduce patient surgical
complications, reduce patient recovery time, and reduce healthcare
costs. One skilled in the art will appreciate that the present
invention can be practiced with embodiments other than those
disclosed. The disclosed embodiments are presented for purposes of
illustration and not limitation, and the present invention is
limited only by the claims that follow.
* * * * *